MAUDE Adverse Event Report: ARTHREX, INC. SCORPION NEEDLE, KNEE; MANUAL INSTR, GENERAL SURGICAL

Model Number	SCORPION NEEDLE, KNEE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, it was reported by an arthrex employee via email that for an ar-12990, knee scorpion and ar-12990n-1, scorpion¿ needle, knee, the tip of needle broke off while using knee scorpion.The needle was faulty.Tip of needle was jammed inside scorpion and it was unable to be used.This was detected during use in a meniscal root repair procedure on (b)(6) 2025.The procedure was completed successfully as sterile smith & nephew mini first pass was used.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause of the reported failure can be attributed to user error of the device due to excessive force being used during firing of the needle thus, breaking the needle and causing a blockage within the shaft.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The complaint allegation was confirmed.One unpacked ar-12990n-1 with serial/batch number 15353646 was received for investigation.The needle was received broken inside the ar-12990 batch number 10296860.Functional testing the ar-12990 batch number 10296860 with a new needle (ar-1990n) revealed resistance when attempting to pass the needle through the scorpion shaft.The instrument's shaft appears to be obstructed, presumably due to a fragment of the needle remaining inside.A visual inspection of the ar-12990 batch number 10296860 revealed a piece of metal, presumably a needle, lodged in the slot of the scorpion's tip.The most likely cause of the reported failure is a use error.

• Brand Name: SCORPION NEEDLE, KNEE
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 22026845
• Report Number: 1220246-2025-02057
• Device Sequence Number: 12572206
• Product Code: MDM
• UDI-Device Identifier: 00888867266520
• UDI-Public: (01)00888867266520(11)241126(17)291031(10)15353646
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SCORPION NEEDLE, KNEE
• Device Catalogue Number: AR-12990N-1
• Device Lot Number: 15353646
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 08/11/2025; 09/03/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 08/12/2025; 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown